FDA fast tracks Roche triple-negative breast cancer treatment

Nov. 13, 2018

Roche has announced that the U.S. Food and Drug Administration has granted priority review for Tecentriq (atezolizumab) plus chemotherapy (Abraxane) for the initial treatment of unresectable locally advanced or metastatic triple-negative breast cancer (TNBC) in people whose disease expresses the PD-L1 protein, as determined by PD-L1 biomarker testing. The FDA is expected to make a decision on approval by Mar. 12, 2019.

If approved, this Tecentriq combination would be the first cancer immunotherapy regimen for the treatment of PD-L1-positive, metastatic TNBC. Currently, Roche has seven ongoing Phase III studies investigating Tecentriq in TNBC, including early and advanced stages of the disease. 

"Tecentriq in combination with nab-paclitaxel has the potential to meaningfully advance treatment for people with PD-L1-positive, metastatic triple-negative breast cancer," said Sandra Horning, MD, Roche’s chief medical officer and head of global product development. "People need more options for this type of breast cancer, which is particularly difficult to treat. We are working closely with the FDA to bring this Tecentriq combination to people with PD-L1-positive metastatic triple-negative breast cancer as soon as possible."

Read the Roche release